Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device
Cmax by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0.
Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device
AUC 0-tlast by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.
Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)

Secondary Outcomes (10)

PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen)
Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen)
Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
PK: Cmax by Body Weight
Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
PK: AUC 0-tlast by Body Weight
Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI)
Week 12
+5 more secondary outcomes

Study Arms (2)

80 mg Ixekizumab Auto-Injector

EXPERIMENTAL

Ixekizumab administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection every 2 weeks (Q2W) at week 2, 4, 6, 8 and 10. Starting from Week 12, 80 mg Ixekizumab Prefilled Syringe was administered by one 80 mg SC injection every 4 weeks (Q4W).

Drug: Ixekizumab Auto-Injector

80 mg Ixekizumab Prefilled Syringe

EXPERIMENTAL

Ixekizumab administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10. Starting from Week 12, 80 mg Ixekizumab Prefilled Syringe was administered by one 80 mg SC injection Q4W.

Drug: Ixekizumab Prefilled Syringe

Interventions

Ixekizumab Auto-InjectorDRUG

Administered SC by auto-injector

Also known as: LY2439821

80 mg Ixekizumab Auto-Injector

Ixekizumab Prefilled SyringeDRUG

Administered SC by prefilled syringe

Also known as: LY2439821

80 mg Ixekizumab Prefilled Syringe

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization
At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
Static Physician Global Assessment (sPGA) score of at least 3 AND Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at randomization
Candidate for phototherapy and/or systemic therapy
Men must agree to use a reliable method of birth control during the study
Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

You may not qualify if:

Pustular, erythrodermic, and/or guttate forms of psoriasis
History of drug-induced psoriasis
Clinically significant flare of psoriasis during the 12 weeks prior to randomization
Concurrent or recent use of any biologic agent
Received systemic psoriasis therapy \[such as psoralen and ultraviolet A (PUVA) light therapy\] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
Have participated in any study with interleukin-17 (IL-17) antagonists, including Ixekizumab
Serious disorder or illness other than plaque psoriasis
Serious infection within the last 3 months
Breastfeeding or nursing (lactating) women

Contact the study team to confirm eligibility.